Renoprotective Effect of Aliskiren Shown

Aliskiren, an oral direct renin inhibitor, may have renoprotective effects that are independent of its BP-lowering effect in patients with type 2 diabetic nephropathy who are receiving the maximal recommended renoprotective treatment and optimal antihypertensive therapy, researchers report.

The finding comes from a randomized study in which 599 hypertensive patients with diabetic nephropathy received aliskiren or placebo in combination with the angiotensin receptor blocker losartan. The two groups had similar baseline characteristics.

After a three-month open-label run-in period during which patients received 100 mg of losartan daily, patients were randomly assigned to receive placebo (298 patients) or aliskiren (301 patients), in addition to losartan, for six months. The aliskiren group received 150 mg of the drug for three months, followed by a dosage increase to 300 mg daily for another three months.

Compared with placebo, treatment with 300 mg of aliskiren daily reduced the mean urinary albumin-to-creatinine ratio by 20%, investigators reported in the New England Journal of Medicine (2008;358:2433-2446). The investigators, led by Hans-Henrik Parving, MD, of University Hospital in Copenhagen, observed reductions of 50% or more in 24.7% of patients who received aliskiren versus 12.5% in placebo recipients.

By the end of the study period, Dr. Parving's group noted a small, non-significant difference in BP between the two groups. The aliskiren and placebo arms had a similar proportion of adverse events (66.8% and 67.1%, respectively) and serious adverse events (9.0% and 9.4%).